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Antimicrobial agent

Phase 2

Diabetic Foot Ulcers (DFUs) | Small molecule | Other |Lakewood-Amedex Biotherapeutics Inc.|Last Updated: May 4, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDBiomarker
Total Trials1
Total Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT07565506Phase 2a Dose Finding Study of Nu-3 Gel in Subjects With Mild iDFUPHASE2 NOT YET_RECRUITING 24 — — Aug 1, 2026Dec 1, 2026May 4, 2026 - —
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Study Endpoints
Primary Endpoints
Primary Efficacy Outcome
From enrollment to the end of day 7 and at the end of treatment at day 14

The rate reduction in CFUs by ≥ 2 logs per pathogen, which is identified as typical and highly suspicious for being the cause of the infection compared to baseline.

Primary Safety Outcome
From enrollment to the end of study participation at 4 weeks

Number of AEs overall and those assessed by the investigators as possibly, probably, and definitely related to the study drug as well as the number of SAEs per patient and cohort.

Secondary Endpoints
Treatment success by dose
From enrollment to the end of treatment at 2 weeks
Treatment failures by dose
From enrollment to the end of treatment at 2 weeks
Secondary safety outcomes
From enrollment to 7 days of treatment, end of treatment at 2 weeks, and end of study participation in the study at 4 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
2.5mg doseEXPERIMENTALTwice daily application for 14 days
5mg doseEXPERIMENTALTwice daily application for 14 days
10mg doseEXPERIMENTALTwice daily application for 14 days
Interventions
NameTypeDescription
Antimicrobial agentDRUGTopical antimicrobial gel application twice a day for 2 weeks
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo

Inclusion Criteria: 1. Male and female subjects ≥18 years of age. 2. Voluntary written informed consent, including information about the provisions of the Health Insurance Portability and accountability act (HIPAA) as applicable. 3. Non-hospitalized ambulatory subjects diagnosed with diabetes melli...

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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT07565506studyFirstPostDate: changed
LOWMay 21, 2026NCT07565506NEW_TRIAL: changed
LOWMay 21, 2026NCT07565506NEW_TRIAL: changed